Archimedic is a contract medical device development firm with offices in the Philadelphia and Boston areas. We work with technology-driven companies to engineer and build electro-mechanical products for medical and consumer wellness applications. Our projects range from IoT wearables to surgical devices to life support systems. We offer a creative work environment with a highly collaborative team, passionate clients, and technically challenging projects.
The Director of Mechanical Engineering role will involve internal and external resource management, program management, technical leadership, and team development. The ideal candidate has proven experience in bringing complex mechanical and electromechanical medical devices through all stages of product development, regulatory milestones and into production.
ESSENTIAL JOB FUNCTIONS:
- Mechanical Engineering Management – Work with internal staff and external contractors to ensure that mechanical engineering is conducted within the project constraints while maintaining quality and consistency in deliverables. Conduct design reviews and technical check-ins on projects routinely.
- Team Building & Team Development – Continuously evaluate mechanical engineering needs and manage hiring plan. Generate job descriptions, manage interviewing process, and on-board new employees. Establish career paths for engineering team and provide mentorship to direct reports. Provide regular feedback to mechanical engineering team members, and perform annual performance appraisals.
- Program Management – Manage multi-disciplinary teams (mechanical engineers, electrical engineers, software engineers, industrial designers) through the development of complex systems. Serve as a client interface on key projects. Prepare project documentation (Gantt charts, action item lists, proposal updates) to ensure full alignment with clients throughout the development process. Ensure that project stays within the allocated timeline / budget, and address scope changes with clients as they arise.
- Quality Management – Improve processes and templates for design control, risk management, and other quality related areas. Work with external quality / regulatory specialists as needed to build Quality Management System (QMS) in compliance with ISO 13485, ISO 9001, and ISO 14971. Train internal team members on QMS.
- Vendor Management – Identify capable vendors that can be leveraged to perform tactical processes. Specify work scope, procure proposals, perform quality audits, and negotiate terms with vendors. Manage vendors throughout projects and address any vendor issues as they arise. Train engineering team to conduct processes uniformly.
- Business Development Support – Collaborate with business development team in sales presentations, project scoping, and proposal development.
- Travel as needed: Occasional overnight travel will be required to service client meetings, supplier meetings, and cross-office work.
OTHER DUTIES AND RESPONSIBILITIES
Any other duties as assigned.
PREPARATION, KNOWLEDGE, SKILLS & ABILITIES:
- Experience with CAD modeling and analysis software, Solidworks experience preferred
- Experience with FDA QSR and ISO 13485 medical device regulations
- Experience with Risk Analysis tools consistent with ISO 14971
- Familiarity with EN 60601, Safety requirements for medical electrical systems and ISO 62304, Medical Device Software Life Cycle Process
- Familiarity with US FDA regulations, i.e. 501(k), IDE, PMA
- Extensive experience (10+ years) managing and developing engineering teams
- Expertise in mechanical and electromechanical medical devices (Class I, II and III)
- Expertise in all phases of product development from concept design through transfer into manufacturing
- Experience in building and refining Quality Management Systems (QMS) for compliance with ISO 13485, ISO 9001, and ISO 14971; Leveraging expertise of external quality and regulatory consultants as required.
- Experience building and maintaining supply chains and transferring products into manufacturing
- Experience working in a fast-moving, small company environment
- Willingness and ability to get hands-on with mechanical engineering tasks
- Work in partnership with others to meet and exceed customer expectations
- Follow through on customers’ inquiries in a professional and timely manner
- Interpret customers’ needs and take appropriate action
- Assure that all verbal and written communications are concise, technically accurate, timely, and professional
- Demonstrate strong listening, communication, and negotiation skills with a positive, professional, and diplomatic demeanor
- Respond positively to changing priorities and remain flexible and resilient during stressful situations
- Adopt new techniques and procedures quickly and employ them into daily job functions
- Previous medical device experience required
Mechanical Engineering staff
WORKING CONDITIONS/PHYSICAL DEMANDS:
Must be able to move throughout the office and laboratory space, using a complete variety of office equipment and laboratory machinery and tools. Must be able to lift more than 30 pounds and stand for extended periods of time. Must be able to use the stairs to move between office floors (no elevator available).
- *External and internal applicants, as well as position incumbents who become disabled as defined under the Americans and Disabilities Act must be able to perform the essential job functions (as listed) either unaided or with the assistance of a reasonable accommodation to be determined by The Senior Leadership Team on a case by case basis.
- This Job Description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
- Archimedic is an equal opportunity employer who considers its team members the cornerstone of the Company’s success. Archimedic does not discriminate against employees or job applicants based on their age, race, gender, religion, nationality or other protected characteristics.
We want to hear from you! If you are interested in any of our open positions or if you wish to be considered for future opportunities with Archimedic, please submit your CV/Resume and cover letter to email@example.com. Please note the position of interest in the subject line.